AFU-GETUG20
- Conditions
- PROSTATIC ADENOCARCINOMA WITH HIGH RISK OF RECURRENCE.MedDRA version: 17.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022037-29-SK
- Lead Sponsor
- ICANCER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 700
1. Patients who have received the information leaflet and signed the consent form
2. = 18 years of age with a life expectancy of at least 10 years
3. Performance Status (ECOG) = 2
4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
5. Histologically confirmed prostatic adenocarcinoma
6. Patients with:
postoperative Gleason score > 7,
or = 7 with the presence of high-grade Gleason patterns (5)
or Patients pT3b whatever the Gleason score
AND with R0, N0 or Nx, M0 in all cases
7. Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery) whatever the Gleason score
8. Neutrophils = 1500/mm3, platelets = 100000/mm3
9. Bilirubin = upper normal limit (this will not apply to subjects with Gilbert’s syndrome, persistent or recurrent hyperbilirubinemia that is predominantly uncongugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT = 1.5 times upper normal limit; Creatinine < 140 µmol/l (or clearance > 60mL/min)
10. Patients affiliated to a social security scheme
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350
1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
2. Presence of metastases:
- positive bone scintigraphy including Patients with medullary compression
and/or
- abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement.
3. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.
4. Incompatible concomitant treatment(s)
5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
7. Persons deprived of their freedom or under supervision (including guardianship),
8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.;Secondary Objective: - PSA evolution<br>- Evaluation of testosterone level<br>- Specific survival<br>- Overall survival<br>- Tolerance<br>- Quality of life (QLQ-C30 questionnaires);Primary end point(s): The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy. <br><br>In case of biological reccurence, the presence of metastases will be evaluated with an abdominal-pelvic CT scan (or MRI) and bone scintigraphy.<br>;Timepoint(s) of evaluation of this end point: 10 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable